Kornimate/medical-research-clean huggingface dataset:
detecting errors in using metered dose inhalers (mdi) among asthma and chronic obstructive pulmonary disease (copd) patients

Conditions: Asthma; Chronic Obstructive Pulmonary Disease

Summary: metered dose inhaler (mdi) and dry powdered inhaler (dpi) are the two most common devices used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary disease. it is well-known that most patients do not use correct technique when using a metered dose inhaler. this leads to poor control of their disease. this study is being done so the investigators can record the patient using the metered dose inhaler before and after a short teaching session. this information will be fed into an invitro system (device) to allow the researchers to study the effect of error on drug delivery. the device being used is the rice r3 electronic flowmeter.

metered dose inhaler (mdi) and dry powdered inhaler (dpi) are the two most common platforms to deliver medicine for patients suffering from asthma and chronic obstructive pulmonary disease, and are used for dispensing both controller and rescue medications. despite well-known methods to manage asthma and copd, nearly 70-90% of the patients do not display correct technique in using an inhaler. poor management and control of the disease due to inadequate inhaler usage has resulted in rising rates of hospitalizations, making chronic respiratory diseases among the top five causes of death worldwide. through this study we aim to record the technique of mdi usage among asthma and copd patient and understand the errors in their technique. the various parameters of inhaler usage where patients can make an error are 1. tidal volume, 2. inspiration flow rate, 3. inspiration flow volume, 4. timing of actuation of inhaler and 5. breath-holding. the parameters will be recorded by the cognita r3 electronic flowmeter for each patient and the errors in each mdi usage will be noted. using ex-vivo modelling, the patient's mdi technique recorded will be used to study the impact of errors in technique on efficiency of mdi drug delivery.

Eligibility criteria:
inclusion criteria: * patients with a physician diagnosis of asthma or copd taking inhaled medications using mdi * age \>18 years * able to read and sign consent document exclusion criteria: * patients having acute exacerbation * patients who are unable to take medication from an mdi
therapeutic plasma exchange in thyrotoxicosis

Conditions: Thyrotoxicosis

Summary: therapeutic plasma exchange (tpe) is indicated in cases where antithyroid medications cannot be used due to the side effects or attain no adequate hormonal suppression response at the highest dosage and in cases of rapid onset of clinical symptoms. this study presents the treatment results of patients who underwent tpe and subsequently operated for thyrotoxicosis.

background: therapeutic plasma exchange (tpe) is indicated in cases where antithyroid medications cannot be used due to the side effects or attain no adequate hormonal suppression response at the highest dosage and in cases of rapid onset of clinical symptoms. this study presents the treatment results of patients who underwent tpe and subsequently operated for thyrotoxicosis. methods: the files of 27 patients who underwent preoperative tpe for thyrotoxicosis between january 1999 and february 2019 were retrospectively analyzed. the demographic and clinical features of the patients were included.

Eligibility criteria:
inclusion criteria: * thyrotoxicosis unresponsive to medication * adverse reaction to the medications * need for rapid treatment in patients that need urgent surgery exclusion criteria: * the patients who did not undergo surgery post-therapeutic plasma exchange * preoperative hypocalcemia, * hemodynamically unstable patients * patients not suitable for central catheter placement
study in paediatric patients with atopic dermatitis treated with dupilumab in spain

Conditions: Atopic Dermatitis

Summary: this is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in atopic dermatitis (ad) patients aged 6 months to 11 years old in spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. as well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. no diagnostic or therapeutic intervention outside of routine clinical practice will be applied.


Eligibility criteria:
inclusion criteria: * male or female aged 6 months to 11 years old at baseline. * patients with severe atopic dermatitis (ad) according to the investigator's assessment. * patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records). * signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age. exclusion criteria: * patients who are participating in an interventional clinical trial that modifies patient care.

Keywords: pediatric
direct and spillover impacts of a community-level hiv/aids program

Conditions: HIV/AIDS

Summary: the hiv/aids crisis in sub-saharan africa has left millions of children orphaned. these children, who are potentially infected with hiv themselves, are highly vulnerable and face some serious risks to their health and overall well-being. a variety of health and economic interventions to help orphans and vulnerable children (ovcs) (and the households in which they live) are being carried out in mozambique by world education inc./bantwana (wei/b), funded by usaid. the program is known in portuguese as força à comunidade e crianças or fcc (in english, "strengthening family and communities"). this study will collect survey and administrative data to assess the impact of the fcc program on ovcs and the households in which they live. a baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics. follow-up data collection will begin in march 2019. it has several components: 1. household survey the follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the fcc program. 2. data collection on hiv testing and school attendance this study will supplement survey-reported hiv testing rates with an objective, administrative measure of hiv testing at health clinics. at the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for hiv at a specified local health clinic. to allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an hiv test. in addition to self-reported data on school participation by children, this study will also measure school participation directly. both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community. 3. informational treatments aimed at raising hiv testing rates to allow insight into the mechanisms through which the fcc program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible fcc mechanisms: stigma reduction, hiv/aids information, and hiv treatment (antiretroviral therapy, or art) information.


Eligibility criteria:
inclusion criteria: * households that lives in one of the eligible communities. exclusion criteria: * households that are not in the eligible communities will not be included in the survey sample.
impact of soft tissue grafts on tissue alterations after immediate tooth replacement

Conditions: Tooth Socket; Dental Implants

Summary: this study evaluates the impact of soft tissue grafts on soft tissue recession following immediate implant, provisional and bone graft placement in compromised sockets. one third of the patients received a collagen matrix (cm group), another third received a connective tissue graft removed from the palate (ctg group) and the final third did not receive any soft tissue graft (ctl group).

preventing soft tissue recession following flapless immediate implant and provisional placement (iipp) in sockets with facial bone dehiscences is a challenge, mainly in esthetic areas. this study evaluated the impact of soft tissue grafts on peri-implant alterations after 1-year follow-up. twenty-four patients with one single failing maxillary incisor presenting facial bone dehiscence and receiving iipp were randomly divided in three groups (n= 8 in each group): control (ctl); collagen matrix (cm); connective tissue graft (ctg). in addition to soft tissue grafts, all groups were treated with collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen. clinical, photographic and tomographic analyses were performed at baseline, 6 and 12 months after surgery to evaluate tissue alterations.

Eligibility criteria:
inclusion criteria: * presence of a failing maxillary incisor with neighbouring teeth and harmonic gingival contour; * operated area with appropriate palatal/apical bone to install the implant; * a buccal wall defect confirmed by cone beam computed tomography; * clinical attachment level \> 3 mm; * good oral hygiene with visible plaque index \< 20%; * no bone loss in the neighbouring teeth; * implant primary stability \> 32n exclusion criteria: * history of periodontal surgeries in the failing tooth; * occlusal instability; * systemic alterations that could compromise the surgical procedure, such ass smokers, bruxists; drug users; patients with diabetes or pregnants. * active infection involving the gingival margin * patients undergoing radiotherapy in the head and neck area. patients presented history of bone associated diseases or medication affecting bone metabolism;

Keywords: gingival recession immediate implant and provisional placement bone graft connective tissue graft collagen matrix
effects of very low-calorie diet versus bariatric surgery on body composition and gut microbiota pattern

Conditions: Obesity

Summary: obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. also, it significantly alters gut microbiota composition and function. a very low-calorie diet (vlcd) is a rapid weight loss program which calorie intake is severely restricted (\< 800 kcal/day). it has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. therefore, this study was aimed to study the effects of 12-week vlcd compare to bariatric surgery (laparoscopic roux-en-y gastric bypass (lrygb) or laparoscopic sleeve gastrectomy (lsg)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.

the study will include obese patients (body mass index; bmi ≥ 37.5 kg/m2 or bmi ≥ 32.5 kg/m2 with comorbidities), aged 15-65 years at ramathibodi hospital, thailand. the vlcd group will received total diet replacement for 12 weeks and the bariatric surgery group will undergo lrygb or lsg. study participants in both groups will be matched according to their age, sex, body mass index (bmi) and diabetic status. body weight reduction and body composition, gut microbiota pattern, liver stiffness and steatosis, glycemic and other metabolic parameters (glucose, insulin, c-peptide, lipid profile, liver function test, kidney function test, complete blood count, electrolyte blood test, thyroid function tests, serum ketone and adiponectin), health-related quality of life, depression score and twenty-four-hour diet recall and physical activity will be assessed at baseline and at month 1, 3, 6, 9 and 12.

Eligibility criteria:
inclusion criteria: * aged 15-65 years * male or female * body mass index ≥ 32.5 kg/m2 with obesity related co-morbidity * body mass index ≥ 37.5 kg/m2 with or without an obesity related co-morbidity exclusion criteria: * end stage disease such as cancer, cirrhosis child-pugh c, critical/acute illness * type 1 diabetes mellitus * recent egfr \< 30 ml/min/1.73 m2 * weight loss ≥ 5% in the previous 3 months * use of antibiotics in the previous 1 month * use of probiotic or prebiotic supplement in form of tablet or sachet in the previous 14 days * current treatment with anti-obesity drugs * pregnancy or breast feeding * substance abuse * uncontrolled psychiatric disorder and eating order * history of allergy to any components in meal replacement product or whey protein product * unable to give informed consent

Keywords: very low-calorie diet bariatric surgery body composition gut microbiota pattern
toward understanding drivers of patient engagement with digital mental health interventions - part ii

Conditions: Depression; Anxiety Disorders

Summary: this study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.

this 8-week, clinical trial involves primary care patients with clinically significant depression and/or anxiety recruited via provider referral. participants will received access to a digital mental health intervention with known efficacy and be randomized to an engagement strategy condition--a previously-validated coach support protocol (cs), a newly-developed automated motivational messaging protocol (amm), both or neither. to further understand how messages in the amm arms function, message delivery will be micro-randomized: each day participants will be randomized to receive a message or not, such that they receive an average of 4.2 messages/week. micro-randomization allows causal inference about the near-term impact of message delivery (i.e., are amms a cue to action) and the relationship between message impact and context (e.g., day in study). measured outcome data will include level of engagement (operationalized as minutes of intervention use) and weekly self-reports of clinical outcomes.

Eligibility criteria:
inclusion criteria: * mass general brigham primary care patient * age 18-75 * clinically significant symptoms of depression (patient health questionnaire-9 (phq-9) greater than or equal to 10) and/or anxiety (generalized anxiety disorder-7 (gad-7) greater than or equal to 8) * owns a smartphone capable of running the study applications * fluent in english. exclusion criteria: * diagnosis of bipolar i or bipolar ii disorder per patient report or the patient's medical record * diagnosis of any psychotic disorder per patient report or the patient's medical record * current substance use disorder per patient report or the patient's medical record * acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).

Keywords: mobile app engagement depression anxiety micro-randomized trial
revital-core program

Conditions: Frailty; Cancer; Chemotherapy-Induced Change

Summary: pilot feasibility study of the revital chemotherapy online resiliency evaluation (core) program. as part of standard of care, patients starting a new chemotherapy regimen are referred to complete a pre-chemotherapy cancer rehabilitation evaluation (i.e., prehab) and invited to enroll in the revital-core program study. once enrolled in revital-core, participants will complete a monthly online evaluation for 1 year. if frailty (or pre-frailty) is detected on any survey, physical or occupational therapy will be initiated for standard of care rehabilitation evaluation and treatment.

all patients starting a new chemotherapy regimen will be referred to completed a prehab evaluation with a specialized physical or occupational therapist be and invited to enroll in the revital-core program for the pilot, feasibility study. participants in the revital-core program study will be emailed an online evaluation each month via for one year. once completed, the evaluation is automatically scored into: frail, pre-frail or robust categories using a validated frailty index. any patient categorized as frail or pre-frail will be re-referred to rehabilitation by their cancer care team. for frail and pre-frail individuals, standard of care rehabilitation therapy will include either/and occupational and physical therapy evaluation and treatment and will be billed via their insurance. the purpose of this pilot study is to evaluate feasibility of the of the revital-core program for individuals starting a new chemotherapy regimen. secondary aims are to evaluate the prevalence, trajectory and predictors of frailty during the first year of chemotherapy treatment; and evaluate the impacts of prehab/rehabilitation for participants identified as frail and pre-frail.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * english speaking * starting new chemotherapy treatment with oncology partner * provide informed consent exclusion criteria: * eligible for hospice care

Keywords: frailty cancer chemotherapy care coordination online prospective surveillance
pharmacodynamics, pharmacokinetics, safety and tolerability of shr3824 in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the pharmacodynamics (pd), pharmacokinetics (pk), safety and tolerability following single and multiple oral doses of 5mg to 20 mg shr3824 in type 2 diabetes mellitus patients.


Eligibility criteria:
inclusion criteria: * bmi:20-35kg/m2; * medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ecg) at screening; * on a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (fpg) concentration lower than 13.9 mmol/l at baseline; * stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (hba1c) between 7.0% and 10.0%. exclusion criteria: * history of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes. * pregnancy or breastfeeding; * significant acute or chronic medical illness, including renal impairment, or recent surgery; * donation of blood or plasma within the 4 weeks prior to the start of the study;

Keywords: shr3824 type 2 diabetes mellitus sglt2
sienna and sentimag in sentinel lymph node biopsy

Conditions: Breast Cancer

Summary: the aim of this study is to evaluate a new method for the localization of breast cancer sentinel lymph node using sienna+® and sentimag® detection in comparison to our standard techniques with radio-isotopes.

the use of radioisotope with or without blue dye has long become the gold standard for sentinel lymph node localization in the management of breast cancer. the latest evidence from a number of european trials has proven that a new tracer agent, superparamagnetic iron oxide particles (spios, sienna+®), is non-inferior to the standard method of lymphatic mapping. its application and feasibility has yet been tried in most asian countries. this is a prospective paired comparison trial involving both the new magnetic technique and the standard method. patients with preoperative diagnosis of invasive carcinoma or ductal carcinoma in-situ of the breast undergoing snoll (sentinel node and occult lesion localization) will be recruited from the breast centre of kwong wah hospital. informed consent will be obtained. all patients recruited will receive subcutaneous injection of 2 ml of sienna+® diluted with saline to 5 ml at breast centre in the morning of operation, followed by five minutes of massage to the injection site. before incision, on-table transcutaneous detection with the handheld magnetometer are carried out after at least 20 minutes from injection. intraoperative counts of sentinel lymph nodes identified as well as the ex-vivo counts of excised nodes are also measured. all procedures are supplemented with localization by radioisotope. all lymph nodes excised will be sent for histopathological examination.

Eligibility criteria:
inclusion criteria: * women diagnosed with early-stage breast cancer (including ductal carcinoma in-situ) who are clinically or radiologically node-negative and consenting for sentinel lymph node biopsy * patients undergoing snoll (sentinel node and occult lesion localization) with the use of radio-isotope in our breast centre exclusion criteria: * patients with clinically t3 or t4 breast cancer and any contraindication to sentinel lymph node biopsy * patients with pacemaker or other implantable device in the chest wall
mental health symptoms and intimate partner violence

Conditions: Domestic Violence; Post-Traumatic Stress Disorder; Depression

Summary: using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues.

using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues. the researchers are looking to see if those who participate in a computer screen and are given referral lists as well as having the computer printout placed on the physician clipboard, will increase physician awareness and recognition as well as patient use of resources compared to usual care.

Eligibility criteria:
inclusion criteria: * female patients between the ages of 18-55 who present to the waiting room of the emergency department during study time periods exclusion criteria: * psychotic * acutely intoxicated * too ill to participate * unable to read * not english speaking

Keywords: suicidality ptsd depression
effect of the consumption of probiotics in the reduction of incidence of carious lesions in preschool children

Conditions: Caries Reduction; Caries Prevention

Summary: probiotics are microorganisms that when administered in adequate amounts can confer health benefits. in vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. a recent study in which preschoolers consumed milk drinks enriched with lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits to children. the aim of this study is to evaluate the effect of daily consumption of milk beverages enriched with lactobacillus rhamnosus on the incidence of caries in preschool chilean children.

in this randomized controlled trial, preschool children belonging to integra foundation will be invited to participate. after obtaining parent´s informed consent, clinical and microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed. differences in prevalence and incidence of caries, dmft and microbial diversity between groups will be assessed.

Eligibility criteria:
inclusion criteria: * healthy children from a general health perspective, with or without cavitated carious lesions at baseline. exclusion criteria: * children with systemic disorders who need special care and / or who have intolerance to milk drinks or allergy to any of the components of the experimental and / or placebo beverage.

Keywords: caries probiotics lactobacilli